Inuniv and Working Memory

This study has been completed.

Sponsor:

Lori A. Schweickert, MD

ClinicalTrials.gov Identifier:

NCT01177306

First Posted: August 9, 2010

Last Update Posted: July 28, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using a standardized battery of tests for effect on symptoms of ADHD and working memory will be administered and assessed.

pre and post testing of working memory in subjects whose ADHD has responded to extended release guanfacine. Subjects will be tested before starting study drug and after 6-8 weeks on a stable dose of the study drug.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

8 Years to 12 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline

2 Outpatient status

3. Age 8-12 (inclusive) at baseline

4. Males or Pre-menarchal females

5. English-speaking parent and subject

6. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant

7. Intellectual capacity to provide assent, as deemed by the Principal Investigator

8. No known cardiac history, including bradycardia, heart block, syncope or tachycardia

9. No known history of hypotension or hypotension at baseline

10. Willing to provide informed consent/ assent per IRB protocol

Exclusion Criteria:

• 1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline

2 Outpatient status

3. Age 8-12 (inclusive) at baseline

4. Males or Pre-menarchal females

5. English-speaking parent and subject

6. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant

7. Intellectual capacity to provide assent, as deemed by the Principal Investigator

8. No known cardiac history, including bradycardia, heart block, syncope or or tachycardia

9. No known history of hypotension or hypotension at baseline

10. Willing to provide informed consent/ assent per IRB protocol 11. No history of hepatic or renal impairment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177306